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Saw this a while ago complements of my brother but was traveling home so I couldn’t post. I had to get word out to my network first. I can’t believe no one is commenting.
I have reason to suspect that Bigger knows more than he is letting out right now. I don’t think this will cause a squeeze on Monday, but hopefully it will lift the price meaningfully.
Approval is so damn obvious, I can’t believe anyone still questions. This news tells me that Lawyer guy who specializes in taking down those who illegally short and has been watching this all happen for a couple years is about to open a can of whoop-ass. Our attorneys here can weigh in and know better than me, but I think the civil folks can collaborate with the criminal folks. I am sure he has a lot to tell the DOJ.
My guess also is we see LC, And all the other usual suspects disappear from this board.
All of my friends, colleagues and family are holding strong…probably at least 8-10 million shares at this point.
I am not sure we are seeing real shares being sold at all.
If we all hold tight, this is just going to make the pending short squeeze that much more enjoyable to watch unfold. SCHADENFREUDE
Leaving Florida now and left with family two weeks ago. Without TSA for all the line two weeks ago was about a half block long to get into the corral of folks. It took an hour and a half to get through. Today, I have TSA which was a few minutes, but the non-TSA line was at least 2 blocks long as it wrapped through the mall, around the corner and all the way back past United ticketing. Everyone is running to gates as I am hearing last calls all over the place. Going to be a very long and hectic day for a lot of families.
I recommend giving your self at least 3 hours if not TSA, maybe more when leaving if Orlando.
LL is a USA physician, and thus cannot prescribe a drug in UK, Canada, or EU.
She presented the statical at Utah with external validation of positive and negative trials. She then went on in May and Mt.Sinai to presnt the model and SAP analysis overview with many forward looking statements about how to think about combing agents with DCVax with a couple case studies. In late summer, she told colleagues to save tissue at patient expense cryogenically frozen rather than paraffin as paraffin will make tissue unsable. Can pretty much guarantee the paper was submitted before this. So LL has seen data and continues to speak positively with expectations to have drug in the hands of other soon. PERIOD
UK and EMEA have approved these endpoints and production capability is ramping up. The 10Q alluded to Franhouffer still being in the mix and we all see Advent nearly done building out an workforce and should receive certification correcting after minor issues loke hiring a fre more people. This tells you 30-40% world revenue will soon be approve.
Flashworks per DI is preparing to do comparability studies with Flashworks which should be all that is necessary to get that to the finish line. This is not an efficacy comparison. My guess is they will need to show similar cytokine profiles on testing and safety of one or two doses in volunteers, probaly in the neighborhood of 20-30 GBM patients. Enrollment by AK et al in UK will be fast. That will not take long at all. That too is “coming soon”. UK/EU is in the bag and it certainly seems that submission there has begun due to the Swaton process for CGMP manufacturing approval.
This all creates revenue in 2022. So how then are we dropping like this. Serious money coming soon there.
On top of that, CRL is already approved for production in US & Canada. Ther is some questions of contracts here, but they too were alluded to as a manufacturer in a recent 10Q. After MT. SINAI, it was clear that the US application could be completed soon. People assume no news means they have not submitted the final data package. I think this is absolutely crazy and that the publication is a smokescreen for this, but absolutely real and on track to be ‘coming soon.’ This is all doubted based on CT.gov not getting updated, really? What of they drop that shoe before Cert and everything else?
Meanwhile they take out a full page add at ABTA which meets the limits of possible coming soon campaigns and remove their exhibit booths that would cross that line if not altered.
Your choice here is that everything is moving forward positively with regulators or that LL and UCLA are implicated in a criminal conspiracy case. Cases can be lost but this is what LL and LP would be conspiring to do along with others. The later is cuckoo bananas, bat $hit crazy.
This ‘bear raid’ is seen in many small biotech as big news is pending. I may have clarity on releasing my powder again soon and I love these prices.
That is how I see the present and near future worl which amounts to Orbis or Orbis like approval in the next several weeks.
FDA rushed to get SPINRAZA on Dec 23 to be ahead of Christmas holiday. That drug is different in many ways, like being a pediatric drug for an orphan disease, that is fatal and in some within months or others who melt away in fromt of their parents over years. They rushed to get er done in about four months.
Just what would they do here? Is what I call a coming soon campiagn happening bc that timeline project Jan-Feb approval in US.
New thought…
It seems to me that a lot of people that are either not so confident or assume doom and gloom believe that NWBO hasn’t even submitted an application or moved forward with a rolling application in the US. While a company can choose not to disclose positive developments, I am pretty sure a refuse to file would be both required to report by SEC rules which creates problems with several other laws and probably made public by FDA. Also current investigators including AK would be required to be informed of a change in any data that shifts perceptions of safety or efficacy and IRBs would require new approvals and all patients be reconsented.
A submission of data that changes this perception would also require these steps be taken. Waiting for some change in rules, as Biosect has suggested would likely mean a submission occurred. FDA is quite busy and backed up by COVID to do back and forth without purpose and intent. NWBO taking advertisement risks along the way of any of these scenarios creates all sorts of new risk. Why would anyone do that and continue to pay Advent to move forward?
Very helpful, Dave and Flip.
Biocomparibilty studies need to registered and patients need to be consented differently than specials program. I haven’t searched, but am confident someone like Lykiri would find this information somehow. You generally do not start new studies during application as FDA may choose to wait and see. Or they can also provide you with confidence to begin. Makes me wonder about LLs little risky trial that could produce unrelated SAEs but still attributed to DCVax. To me it seems like no one is worried about process or label implications.
Agree with you both and also love Docs analogy.
Emotion is very difficult to control once tipped into scare or panic. Why was there a sudden drop after holding steady all day, but into the weekend? I can’t see any trigger to panic except for stock dropping.
What long would sell at these prices? What short time buyer would sell at these prices? What IS the explanation for this other than emotional manipulation? My ears are open and have been despite 8 years of convictions. I have my own confidence in my own experience and knowledge, so any answers must be very good to change this
I understand your point of view and respectfully disagree. Either way, you generally belive things continue to move in a positive direction.
Think of it this way. The other side continues to poke fun at me about the tote bag, but as far as I can tell with my limited reading, they have stayed away from the full page American BRAIN TUMOR Association advertisement. Why is this?
There are three options here:
1) I know WTF I am talking about
2) If you believe this is a judgement call, it represents significant risk.
3) If it is an attempt to carry on a charade, this presents even more risk and includes LL and UCLA in that risk.
Logic should help to answer that for you. Remember though that LL told her colleagues on video which means enduring around ABTA to save tumor tissue by cryogenic freezing and not paraffin. There are safe harbor issues with this, but this would not need an FDA penalty to be of value. She is actively supporting the product and is giving guidance to spend personal assets amongst people who desperately need to reserve assets. Do you really believe she would mislead her colleagues and draw them into a scam? Do you think she is heartless and does not care about the overall health of patient and family?
The value of that tissue has a ticking clock which is not long. Does this help you choose options here?
Nope, they chose the path on which they walk. Unlike what Led Zepplin will tell you, before climbing the stairway you cannot always change the road you are on.
But sometime you do have an EPIPHANY before that choice need be final
WI Dendream, but my lake home ended up elsewhere
You think that you are funny, but we shall see who is laughing at whom come Easter. SCHADENFREUDE
Well, I think I have pointed out that should the absolutely absurd improbability occur, there should be alternative recourse which also ties in LL and the UCLA. Completely absurd, but I guess the truth is an infinitesimal chance.
The sacred geometry of chance, the hidden laws, and probable outcomes…the numbers lead a dance.
Where you on i-village? Do you remember me? I went by a different handle.
Do you remember ex? He did as well
To change the endpoints reveals the answer
It will most certainly be the trigger for a short squeeze, although there could be two in rapid succession.
In Slavic countries, while Christmas is celebrated it is the Epiphany that is the big celebration.
EPIPHANY…what a beautiful word. It is rich and deep, just like GESTALT.
I believe the Epiphany happened on January 12th for Christians, for longs it may come a little bit later, but it would be poetic to release something big on that day.
Thank you for this CherryTree. I hope to meet you some day. My opinion FWIW and I stress to all for now it is opinion…you not only made a wise move, it is absolutely a no brainer.
What is interesting is to look who the moderators are, and then observe what happened to me two nights ago. I added to another posters observation by explaining my view on the psychology and gave an analogy to another similar industry. It was taken down before I could go back in an edit with no justifiable reason.
I won’t share what I know and how I know it… It is a little like the US Army Campaign
Be all that you can be? How long and why not?
And the study name was EPHESUS, and a clue is that it was their HF study
Pharmacia take over - eplerenone
I don’t speak with him anymore because I wanted my opinion to be free from his influence because he is quite good at his job. I do however appreciate when people share their own insights from DI.
I do appreciate the complements all, but it is Linda & Linda who deserves the complements. I don’t hug generally, but hope she will let me hug her some day.
Thanks, and I did understand this. I was horrible at dating, I could never ask for digits and I don’t usually today, although I hung up my dating hat 28 years ago. I am usually quite direct, but can be passive when in certain situations.
It seems to me that lately my critics can only jab silly arguments like ‘you act too certain’ ‘you make it seem like the company said this or that’
Read my disclaimer from earlier posts and invest at your own risk. Certainty, like integrity, are in the eyes of the beholder and presenter. I am sure those on the other side believe they act with integrity, and according to their view they do. Not mine, but theirs likely.
Thank you Cherry Tree - I love this type of trivia. I thought it was fowl (bird) because of the connotation and believe it or not, have never read MacBeth.
Us Longs, in my opinion, should be thanking LP for the wonderful opportunity she has given us to realize our dreams…this is a rare thing to be able to accomplish in one fowl swoop.
I am not out of gunpowder but my rifle has been taken away from me by a loved one…to be honest, I can’t make a meaningful difference to my sharecount at these prices. Perhaps our friends on the other side of the aisle will be successful in changing that equation.
Nonetheless I don’t need more shares, my dreams and the dreams of my children are already taken care of, and my puzzle solving skills are likely best served in another company. Soon they will be applied to starting a charitable foundation aimed at helping other adults like me who were not given as many blessings as I have been given by my creator.
Then allow me to clear something up for you…
You have been witness to cloak and dagger, skullduggery. You have been asked to choose sides. Pssst…the data will not be released until FDA approval is knocking on the door. The other side has come to realize this, hence we fall one last time.
The meaning of an unchanged number of shareholders is that long have held strong and even grown through thick and thin. If we hold the line the others are absolutely sckrewed so they try and try to shake us loose, but we stand firm together and fueled by this board.
They all only serve to strengthen our resolve.
I have only dumped due to disability and regret the pressure to do so. When accusations are made like that against the other side they are quickly removed. When insights into the other side are made they are bashed if felt conceivable, but removed if not.
The truth is in the eye of the beholder and most of us understand your truth, I try to share mine…sometimes with artistic license.
PQR, I am sorry not to have responded to your inmail. I value privacy which is why I can’t reply privately. I won’t pay for this service. I have been trying to think of a way to give you my digits but I cannot.
I would love to connect some time. I am only in Western Michigan summertimes.
To recognize truth is to find the answers…
My prediction is that the full details may never be fully released. Why?
It is a competitive marketplace and knowledge is power. Do you think people give up easily? They do not in most cases, especially successful people.
Crashes can easily be manufactured on OTC.
Yawn
My friends and colleagues on this board. I will try hard not to have a sharp tongue with you if unjust. I am going through a stressful period, and my personality types’ fall back is to strike back. I will commit to do my best. I find this board and your thoughts soothing. I no longer need your help solving this puzzle, that is what I like to do, but I still enjoy seeing the pieces fall into place. I already know the answer once I saw the full page add, and somethings can only be fully understood if you have walked that path yourself.
He deals the cards as a meditation, those he plays never suspect. He doesn’t play for the money he wins. He don’t play for respect. He deals the cards to find the answers. The simple geometry of fate. The hidden laws, and the probably outcomes…..the numbers lead a dance.
Awesome stuff, Thank you all!
Boy has my anxiety over this company been swept away. I can relax and not watch stock price at all knowing that I have already won and that Linda has all things taken care of already…or at least once MRHA sends their letter.
HOLD the LINE MY FRIENDS.
Do not fear, fear is the mind killer. Fear is the little death that will lead to total obliteration.
I will face my fear, allow it to pass over and through me, and will then turn my minds eye inward to see its path.
Where fear has gone, only I will remain to watch this SHORT SQUEEZE unfold.
I may just pay Elan Muck for a trip round the world.
My reply was for public consumption and to Guzzie, but since I appreciated what you said I didn’t want it dropped from the thread. I think the case of Aduhelm is a perfect example of Congress, some in medicine and the media manipulating public opinion for self-interest, and frequently like to use my industry as the punching bag Boogey man.
I may have angered my medical colleagues, sometimes misdirected, with my sharp tongue because they contribute to demeaning and debasing my industry. An industry that brought you Covid Vaccine, every one of the things used to treat cancer and a whole host of other examples. Add the device industry and physicians would have only the old arcane treatments to offer, inclusive of blood letting. It is a mutually beneficial relationship for us and for patients.
If one is really interested in saving healthcare dollars they would first direct their attension to insurers and other middle men who put up costly hurdle after hurdle to restrict care. They would next turn their eye on institution where the next biggest chunk is and is why physicians need to stop criticizing us. There is actually only a couple pennies on the dollar to remove from the cost of healthcare if you turned us into charitable, nonprofit organizations.
Aduhelm wasn’t dirty and sometimes mistakes are made in the attempt to advance medicine. As I said, FDA weighs patient input over the advisory panel in most cases as here with Aduhelm.
There will be nothing produced by this silly investigation into Aduhelm. Simply, FDA has more faith in Biogen than any other company because of how they handled everything related to Tysabri ideally, including building the strongest risk map that balanced patient desire with patient and physician security. Then they continued to make it safer, but demand did not slip, so it was a Blockbuster until something slightly safer with similar efficacy came out.
They both knew of this safety risk which is why they restricted the study and it’s use to patients with a low beta-amyloid burden. The drug is designed to help the immune system remove amyloid plaques. They hoped the commercial market would follow this guidance, but alas it did not. Now patients with too much amyloid burden are have issues with a robust immune response in the one organ that has no space to expand. It is literally the only organ completely encased bone. It does not do well with inflammation.
I could have just saved the taxpayers a whole lot of money, but not only does my opinion have no weight but Congress loves a good smokescreen so that they can ignore the tough work that would lead to being voted out if an ignorant constituency listenes to lying biased pundants which news media calls news but is unfounded opinion from both sides most of the time.
Check - you don’t like that Linda drops clues with out say things outright
Check - you don’t like that Linda is a shrewd business woman
Check - you don’t like that she preferred to build out capabilities to manufacture in a company she has stake vs building them out for someone else
Check - I assume this means you don’t like Flashwork either
Check - it sounds like you don’t like that Linda got the endpoints changed to a slam dunk
Check - basically you really don’t like Linda
I assume that is because you know deep down that you are about to lose a lot of money soon, and the best you can try is to bring up old pointless stuff to try to finally get longs to release share. The reason in my mind HF continues to try is precisely that, you can’t get longs to shake loose shares no matter how far down you drive it which has made matters much worse for you. Why else would you hang around here?
Totally agree - to me all these things add up to a Journal article soon and possibly in NEJM
Totally agree, thanks for adding your insights
This makes me smile